Systems Engineer

Stefanini Group•Milwaukee, WI

2d•Onsite

About The Position

Stefanini Group is hiring! Stefanini is looking for Systems Engineer in Milwaukee, WI. Responsible for coordination and management of system design for one or more groups of related products (i.e., Programs) to achieve defined program goals. This includes work related to the maintenance and engineering support of existing products. Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues related to each product.

Requirements

Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering or related field and/or equivalent experience.
3+ years of relevant experience.
A demonstrated track record in system development – covering requirements management, risk management, cybersecurity, usability, performance, and reliability.
Experience in using tools/practices like QFD, Pugh Matrix, CTQ, DFR, DFX.
Excellent communication, interpersonal and leadership skills
Firm decision maker and shall possess good influencing skills.
Openness to collaborate in interest of project/organization.
Must have strong organizational skills.
Must be fluent in English (both oral and written) with excellent oral and written communication skills.
Works independently, is self-motivated and able to complete tasks with minimal supervision.
Must have the ability to initiate and develop creative solutions.
Acts with a sense of urgency illustrate ambition and drives for completion of tasks/projects.
Strong proficiency in Office applications skills.
Must be a team player, possess outstanding customer service skills and be self-motivated.
Possess good listening skills and easily learn new skills and concepts.
Ability to manage time and prioritize work.
Must be flexible and adaptable.
Possess the ability to manage time and prioritize critical priorities.
Must demonstrate the ability to increase knowledge.

Nice To Haves

Systems development experience in diagnostic cardiology medical devices or any other medical device is a definite plus.
Agile product development experience preferred.

Responsibilities

Accountable for the entire product development process - from engaging with customers and marketing to compose and develop user needs, to the eventual product launch.
Work with Engineering Project Management to define and scope projects to achieve program goals.
Participate as a member of project teams for the assigned program.
Work with Upstream Marketing to understand and translate market needs into technical product requirements.
As a leader of the technical team, ensure technical product requirements are communicated and understood by the development team.
Owner of the Design History File (DHF). Responsible for ensuring technical product requirements are clearly and thoroughly documented.
Creation of system level specifications.
Ensure usability requirements are adequately addressed per IEC 62366.
Lead technical resources for Risk Management per IEC 14971.
Coordination and review of design level requirements to ensure they meet the system requirements and market needs.
Coordination and review of system and design level requirements to ensure they adequately consider serviceability and manufacturability of the product.
Responsible for DHF traceability by ensuring all requirements have been verified and validated.
Creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project.
Completion of all documentation required to ensure compliance to standards.
Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible.
Work with technical writing to ensure user documentation is sufficient.
Plays a critical role in product development, making sure the product meets all the functional and performance requirements, and ensuring the manufacturing and service requirements are translated into product design.
Lead the development and documentation of the product systems architecture and systems level design, including the decomposition of the system architecture and requirements into subsystem and interface specifications.
Provide technical leadership to the development team to ensure that the project successfully meets cost, quality, and schedule targets throughout the product life cycle.
Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
Plan and carry out system integration tasks to reduce problems in systems verification and validation.
Document traceability from requirements to verification activities, and from requirements to design entities.
Resolve system-related technical issues by applying problem solving tools such as cause-and-effect diagrams, Pareto charts, etc.
As lead integrator for the product, proactively look out for integration issues during development tests and ensure module/system development is successful.
Adheres to clients Quality Management system & supports the quality audits.
Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary to meet the market needs.
Performs other duties as requested.